NEW JERSEY REGISTER
VOLUME 36, NUMBER 12MONDAY, JUNE 21, 2004
RULE ADOPTION
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
ADMINISTRATIVE RULES OF THE DIVISION OF CONSUMER AFFAIRS
NEW JERSEY UNIFORM PRESCRIPTION BLANKS PROGRAM

Adopted New Rules: N.J.A.C. 13:45A-27

Proposed: September 15, 2003 at 35 N.J.R. 4172(a).

Adopted: January 8, 2004 by the Division of Consumer Affairs, Reni
Erdos, Director.

Filed: May 27, 2004 as R.2004 d.238, with substantive and technical
changes not requiring additional public notice and comment (see N.J.A.C.
1:30-6.3).

Authority: N.J.S.A. 45:14-14.1 et seq.

Effective Date: June 21, 2004.
Expiration Date: October 20, 2005.

Summary of Agency Initiated Changes:

The Division has made a technical amendment to new rule N.J.A.C. 13:45A-
27.7(e), on adoption, to correct the cross-reference provided in that
subsection. As proposed, subsection (e) provides, in part, that the
notice of withdrawal or termination submitted by a vendor who is leaving
the NJPB program must include all information that is required to be
maintained in the vendor database pursuant to N.J.A.C. 13:45A-27.8.
The database requirements for vendors, however, are set forth in N.J.A.C.
13:45A-27.9(h). The Division has amended N.J.A.C. 13:45A-27.7(e) on
adoption to refer to N.J.A.C. 13:45A- 27.9(h).

In addition, the Division has amended N.J.A.C. 13:45A-27.8(n), on
adoption, to correct the cross-reference provided in that subsection.
As proposed, subsection (n) provides, in part, that vendors shall not
produce NJPBs that contain ink that is of a different color than the
colors specified in "(a) above." Subsection (a), however, does not contain
any reference to the colors which may be used on an NJPB. Subsection
(n) should have provided that a vendor shall not produce NJPBs that
contain ink that is a different color than those colors specified throughout
the section because several subsections of the rule reference permissible
ink colors. The Division, therefore, has amended N.J.A.C. 13:45A-27.8(n),
on adoption, to delete the reference to "(a) above" and has replaced
it with a reference to "this section."

Federal Standards Statement

A Federal standards analysis is not required because the new rules
are governed by N.J.S.A. 45:14-14.1 et seq., and are not subject to
any Federal standards or requirements. Although the new rules in Subchapter
27 are not subject to any Federal requirements or standards, the Director
has determined that licensed prescribers should comply with Federal
DEA regulations concerning the transmission of prescriptions for narcotic
substances for direct administration to patients by parenteral, intravenous,
intramuscular, subcutaneous or intraspinal infusion, for Schedule II
narcotic substances for hospice patients, and for Schedule II substances
for long-term care facility residents, in order to ensure uniformity
in the transmission of such prescriptions. Therefore, N.J.A.C. 13:45A-27.3(f)
provides that licensed prescribers must comply with the relevant provisions
of the DEA regulations set forth in 21 C.F.R. 1306.11.

Full text of the adoption follows :

SUBCHAPTER 27. NEW JERSEY UNIFORM PRESCRIPTION BLANKS PROGRAM

<< NJ ADC 13:45A-27.1 >>

13:45A-27.1 Purpose and scope

(a) The rules in this subchapter implement the provisions of P.L.
1996, c.154, the Uniform Prescription Blanks Act, supplementing N.J.S.A.
45:14-1 et seq., an act regulating the practice of pharmacy in the State
of New Jersey.

3. All licensed pharmacies which fill prescriptions or medication
orders pursuant to N.J.A.C. 13:39; and

4. All vendors authorized to manufacture and distribute New Jersey
Prescription Blanks pursuant to N.J.A.C. 13:45A-27.7.

<< NJ ADC 13:45A-27.2 >>

13:45A-27.2 Definitions

As used in this subchapter, the following words and terms have the
following meanings unless the context clearly indicates otherwise:

"Address of record" means an address designated by a licensed prescriber
which is part of the public record and which may be disclosed upon request.
"Address of record" may be a licensed prescriber's home, business or
mailing address, but shall not be a post office box.

"Division" means the New Jersey Division of Consumer Affairs.

"Licensed healthcare facility" means any facility licensed by the
New Jersey Department of Health and Senior Services including hospitals,
long-term care facilities, ambulatory care facilities, residential drug
treatment facilities, and alcohol treatment facilities which have been,
or are eligible to be assigned, a Division of Consumer Affairs uniform
prescription blank unique provider number.

"Licensed prescriber" means any healthcare practitioner authorized
by law to write prescriptions.

"New Jersey Prescription Blank (NJPB)" means a uniform, non-reproducible,
non- erasable safety paper form developed by the Division pursuant to
N.J.S.A. 45:14-14.6 which satisfies the specifications of N.J.A.C. 13:45A-27.8.

"Prescription" means an order for drugs or controlled dangerous substances,
or any combination or mixture thereof, or other prescribed items, written
or signed by a licensed prescriber for the diagnosis, treatment, prevention,
or amelioration of disease, injury, pain, or physical condition in man
or animals. For the purposes of this definition, the term "other prescribed
items" includes eyewear, medical devices, orthotics and prosthetics,
and syringes.

"Vendor" means any person authorized to manufacture and distribute
NJPBs pursuant to the rules in this subchapter. For purposes of this
definition, "person" means an individual, partnership, limited liability
partnership, limited liability company, corporation or any other business
entity.

<< NJ ADC 13:45A-27.3 >>

13:45A-27.3 NJPB required for prescriptions

(a) A written prescription issued by a licensed prescriber shall appear
on either the personal NJPB of the licensed prescriber or the NJPB of
a licensed healthcare facility obtained from a vendor approved by the
Division pursuant to this subchapter.

(b) A licensed prescriber affiliated with a healthcare facility licensed
pursuant to P.L. 1971, c.136 (N.J.S.A. 26:2H-1 et seq.), may use the
NJPB of the licensed facility provided that:

1. The prescription is written for a patient treated at that healthcare
facility;

2. The name and license number of the licensed prescriber is legibly
written, typed, stamped, or otherwise affixed to the NJPB;

3. The prescription contains the signature of the licensed prescriber;
and

4. If the prescription is for a controlled dangerous substance, the
licensed prescriber's Federal Drug Enforcement Administration (DEA)
registration number is legibly written, typed, stamped, or otherwise
affixed to the NJPB.

(c) A separate NJPB shall be utilized for each prescription written
for a controlled dangerous substance. No other medication shall appear
on the prescription.

(d) If a licensed prescriber utilizes an NJPB pre-printed with multiple
drugs, the prescriber shall obliterate, by a cross-off procedure, any
drug that is not being prescribed.

(e) A prescription transmitted verbally or transmitted electronically
by telephone, facsimile, modem, or other means to a pharmacy by a licensed
prescriber shall be exempt from the requirement of utilizing an NJPB
if the licensed prescriber provides the pharmacist with his or her license
number and DEA number, as appropriate to the particular prescription,
at the time of transmission of the prescription, and the pharmacist
satisfies the requirements of N.J.A.C. 13:39-5.8, 5.8A or 5.8B.

1. A prescriber licensed by the State Board of Medical Examiners who
transmits a facsimile or electronic prescription shall also comply with
all requirements set forth in N.J.A.C. 13:35-7.4 and 7.4A.

(f) A licensed prescriber writing a prescription for a <<-narcotic->>
Schedule II <<-controlled->> <<+narcotic+>>
substance <<+to be compounded for direct administration to a patient
by parenteral, intravenous, intramuscular, subcutaneous or intraspinal
infusion, or a prescription for a Schedule II narcotic substance+>>
for a hospice patient, or a prescription for any Schedule II <<-controlled->>
substance for a long-term care facility resident, shall be exempt from
the requirement of utilizing an NJPB if the prescription is transmitted
or prepared in compliance with DEA regulations as set forth in 21 C.F.R.
1306.11(d), (e), (f) and (g), consistent with the requirements set forth
at N.J.A.C. 13:39-5.8, 5.8A or 5.8B.

1. A prescriber licensed by the State Board of Medical Examiners writing
a prescription for a <<-narcotic->> Schedule II <<-controlled->>
<<+ narcotic+>> substance <<+to be compounded for
direct administration to a patient by parenteral, intravenous, intramuscular,
subcutaneous or intraspinal infusion, or a prescription for a Schedule
II narcotic substance+>> for a hospice patient, or a prescription
for any Schedule II <<-controlled->> substance for a long-term
care facility resident, shall also comply with all requirements set
forth in N.J.A.C. 13:35-7.4 and 7.4A.

4. The date, the quantity, and to whom the NJPB pads were distributed
at a group practice office or healthcare facility, if applicable;

5. The designation of a person responsible for the ordering, receipt,
storage, maintenance, and distribution of the NJPB pads. NJPB pads shall
not be ordered, received, stored, maintained or distributed by anyone
other than the licensed prescriber or healthcare facility, or persons
employed by the licensed prescriber or healthcare facility; and

6. The designation of a secure storage area for the NJPB pads.

(b) All licensed prescribers and healthcare facilities shall establish
and implement a security protocol for the storage, maintenance, and
distribution of NJPBs.

(c) All licensed pharmacies shall establish and implement a security
protocol for the storage and maintenance of prescriptions issued on
NJPBs and shall consecutively number and file such prescriptions pursuant
to N.J.S.A. 45:14- 15.

(d) Licensed prescribers and healthcare facilities shall notify the
Office of Drug Control in the Division as soon as possible but no later
than 72 hours of becoming aware that any NJPB in their possession has
been lost, stolen, or altered in any way. An incident report shall be
filed in writing with the Office of Drug Control within seven days after
such notification on a form provided by the Office of Drug Control.

<< NJ ADC 13:45A-27.5 >>

13:45A-27.5 Group practice

(a) A group practice may utilize individual NJPB pads for each licensed
prescriber affiliated with the practice, or may utilize NJPB pads listing
multiple prescribers affiliated with the practice, provided that multiple
prescriber NJPB pads contain check-off boxes to indicate which prescriber
issued the prescription.

(b) A group practice using an NJPB listing multiple prescribers shall
obtain new NJPBs within 30 days if the composition of the practice changes,
except as provided in (c) below. Any remaining NJPBs of the former group
practice shall be destroyed and the newly formed practice shall file
an NJPB destruction form with the Office of Drug Control.

(c) If the composition of the group practice is changed through the
addition of a licensed prescriber, the newly formed group practice may
continue to use the NJPBs of the former group practice, provided that
the licensed prescriber who becomes newly affiliated with the group
obtains individual NJPBs with the information required pursuant to N.J.A.C.
13:45A-27.8.

<< NJ ADC 13:45A-27.6 >>

13:45A-27.6 Vendor application

(a) An applicant to become an approved NJPB vendor shall submit an
application on a form supplied by the Division, which shall include
the following:

1. Documentary evidence of experience in large volume printing and
distribution activity;

2. Organizational staffing plans;

3. Documentation that the applicant is financially viable;

4. A written description of the work output capacities of the physical
plant(s), the size and location of the plant(s), the equipment list,
and security measures;

5. The subcontractor company name, address, telephone number, ownership,
and equipment list and the details regarding the subcontractor's production
of any portion of the NJPB, including the security that will be provided,
if an applicant intends to subcontract any portion of the NJPBs; and

6. The name and address of a designated agent in New Jersey for service
of process, notices and/or orders.

(b) All information submitted by the applicant may be verified by
on-site inspection by the Division or its authorized representative.

<< NJ ADC 13:45A-27.7 >>

13:45A-27.7 Manufacture and distribution by approved vendors; withdrawal
or termination from NJPB program

(a) NJPBs shall be manufactured and distributed by vendors approved
by the Division pursuant to N.J.A.C. 13:45A-27.6. A vendor who has failed
to comply with the requirements of this subchapter or the NJPB program
contract specifications shall not be approved for the manufacture or
distribution of NJPBs.

(b) A vendor may withdraw from the NJPB program upon 14 days written
notice to the Division. A vendor that voluntarily withdraws from the
program shall notify, in writing, at least 30 days prior to withdrawal,
each licensed prescriber and healthcare facility that ordered NJPBs
from the vendor within the previous six months.

(c) An approved vendor may be terminated by the Division upon 14 days
written notice for any inability to comply with the requirements as
set forth in this subchapter or the NJPB program specifications. The
Division shall provide the vendor with the opportunity to respond in
writing to any allegation of an inability to comply with NJPB program
requirements. A vendor that is terminated by the Division shall notify,
in writing, within seven days of such termination, each licensed prescriber
and healthcare facility that ordered NJPBs from the vendor within the
previous six months.

(d) A vendor that voluntarily withdraws from the NJPB program or is
terminated by the Division shall either destroy or forward all materials,
computer disks, plates, mechanicals, negatives, and other equipment
related to the production or distribution of NJPBs to another approved
vendor or the Division within seven days of notice of withdrawal or
termination. If the vendor that withdraws or is terminated from the
NJPB program does not forward all materials related to the production
and distribution of NJPBs to the Division, the vendor shall provide
to the Division a certification verifying the destruction or disposition
of such materials.

(e) A vendor that voluntarily withdraws from the program or is terminated
by the Division shall submit to the Division a list of all licensed
prescribers and healthcare facilities that ordered NJPB pads from the
vendor within the previous six months. The list shall be submitted within
seven days of notice of withdrawal or termination and shall include
all the information that is required to be maintained in the vendor
database pursuant to N.J.A.C. 13:45A-<<-27.8->><<+27.9(h)+>>.

(f) Any person manufacturing or distributing NJPBs without approval
by the Division shall be subject to prosecution for theft and/or forgery
by appropriate criminal authorities pursuant to N.J.S.A. 2C:20-2 and
2C:21-1 et seq.

(g) Any person manufacturing or distributing NJPBs without approval
by the Division shall be subject to an action to cease and desist, and
any other action authorized by law.

2. Printed on either 50-pound white offset smooth finish paper with
a brightness of at least 85 or 20-pound paper with a brightness of at
least 85.

(c) The front side of each NJPB shall be printed with the body copy
(line work) in PMS 299 blue overprinted on a background of five percent
of the blue (with an allowable variance no darker than PMS 300 blue).

(d) The background of the front side of each NJPB shall be a pantograph
of the New Jersey State Seal reversed out of the blue screen and shall
bleed on all four sides. A one and one-half inch State Seal shall be
positioned centrally within the pantograph of State seals.

(e) The upper portion of the front side of each NJPB shall include
the batch number, and the prescriber or healthcare facility name, the
prescriber or healthcare facility address, which may be an address other
than the address of record, but which shall not be a post office box,
the license, certification or authorization number of the licensed prescriber,
or the provider number of the healthcare facility, which shall all be
printed in black ink.

(f) The prescribing area of the front side of each NJPB shall contain
an "Rx" graphic circumscribed within a rectangle, printed in blue ink
on the left hand side.

(g) The reverse side of each NJPB shall contain a pantograph of the
New Jersey State Seal printed in PMS 332 green screened down to five
percent (with an allowable variance up to PMS 333 green) which shall
bleed on all four sides. A one and one-half inch State Seal shall be
positioned centrally as on the front, except that it shall not be in
reverse.

(h) Except as provided in (i) below, the front side of an NJPB may
be imprinted with the name and license number of more than one licensed
prescriber in the same licensing category provided that:

1. The name and license number of each licensed prescriber is printed
in a seven point font or greater; and

2. The NJPB utilizes a printed method, such as a check-off box, to
indicate which prescriber issued the prescription.

(i) NJPBs for physician assistants, certified nurse midwives and advanced
practice nurses shall be imprinted only with the name and license number
of the prescriber and his or her collaborating/ive physician.

(j) NJPBs for healthcare facilities shall be imprinted with sufficient
space to allow a prescriber affiliated with the healthcare facility
to write out his or her name, title, license number and collaborating/ive
physician, if applicable, in the titlehead portion of the NJPB.

(k) At the request of a licensed prescriber or licensed healthcare
facility, NJPBs may be pre-printed with the following:

1. Frequently used non-controlled prescription drugs. The prescription
shall be printed in a seven point font or greater. The prescription
may be pre- printed with several non-controlled drugs, delineated by
check-off boxes, provided that separate directions for use, substitution,
and refill instructions shall be clearly delineated for each drug prescribed;

2. A drug identifier bar code placed in the medication prescribing
area, provided that the bar code shall not conceal any information contained
in the medication prescribing area;

3. On the reverse side of the NJPB, any alternative practice address
requested by the prescriber, with a check-off box to indicate the practice
site at which the medication was prescribed. Vendors may utilize up
to one half of the back of the NJPB to pre-print addresses, provided
that at least three quarters of one inch remains at the top of the reverse
side of the NJPB to permit the fastening of NJPB into pharmacy prescription
binders;

4. The statement "NOT VALID FOR CONTROLLED SUBSTANCES" on the face
of the NJPB in black ink;

5. DEA numbers; and

6. Consecutive numbers (serialized).

(l) In addition to the pre-printed requests set forth in (k) above,
NJPBs may be printed to include the following special order requests
in black ink only:

1. In the titlehead portion of the NJPB, the individual prescriber
CDS or DEA numbers, Medicare Provider Numbers; Specialty Practice License
numbers; fax numbers and/or more than one telephone number;

2. Special print, logotype lettering to designate the name of the
healthcare facility or group practice on the first line of the NJPB
titlehead; and

3. On the reverse side of the NJPB, a financial interest disclosure
statement for licensees of the State Board of Medical Examiners, pursuant
to N.J.A.C. 13:35-6.17.

(m) Any request for a pre-printed or special order NJPB not included
in (k) or (l) above shall be approved by the Division before the NJPBs
are produced.

(n) Vendors shall not produce NJPBs that contain logos, symbols, icons
or graphics, or that contain ink that is of a different color than the
colors specified in <<-(a) above->> <<+this section+>>,
or that contain pre- printed physician initials in the "Do Not Substitute"
or "Substitution Permissible" portion of any NJPB.

(o) NJPBs shall be produced in prescription pads of 50 or 100 NJPBs
per pad with chipboard backers.

<< NJ ADC 13:45A-27.9 >>

13:45A-27.9 Vendor requirements

(a) A vendor may produce NJPB pads for a licensed prescriber or licensed
healthcare facility consistent with the requirements of N.J.A.C. 13:45A-
27.8, provided that:

1. The request for NJPBs is in writing and contains the original signature
of the licensed prescriber; and

2. The vendor verifies that the prescriber's license is active and
in good standing and the address of record in the Division's database
or in notices sent to the vendors. The Division database shall be updated
and provided to all authorized vendors on a quarterly basis.

(b) A vendor may produce NJPB pads for a group practice with the name
and license number of more than one licensed prescriber, consistent
with the requirements of N.J.A.C. 13:45A-27.8, provided that:

1. The request for NJPBs is in writing and contains the original signatures
of all the licensed prescribers listed on the NJPB; and

2. The written request designates one licensed prescriber for receipt
of the NJPB shipment.

(c) Vendors shall ensure the identity and authority of the prescriber
or healthcare facility to utilize NJPBs prior to printing or delivering
any order for NJPBs.

(d) Vendors shall deliver NJPBs within 14 days of receipt of an initial
order, or seven days for a reorder, in sealed packets in minimum quantities
of 500. Such deliveries shall be made to the address of record on file
with a Division via a secure delivery service which is capable of tracking
the shipment. Delivery of healthcare facility NJPBs shall be made only
to the healthcare facility official designated as the responsible party
when the order was placed, and only to the healthcare facility address.
If a discrepancy exists between the order delivery information and the
address which appears on file with the Division, the vendor shall verify
the prescriber address information with the prescriber's licensing board.
If a vendor is unable to deliver the NJPBs within the time specified
above, the vendor shall immediately notify the licensed prescriber or
the healthcare facility of the delay in the processing of the order.

(e) A licensed prescriber may pick up NJPBs at a vendor's place of
business provided that:

1. The licensed prescriber provides documentation verifying his or
her identity and licensure;

2. The vendor verifies the licensed prescriber's signature; and

3. The vendor remains responsible for the security of the NJPBs delivered
in this manner.

(f) Vendors shall be capable of producing NJPBs in the following forms:

1. A single non-erasable NJPB form; and

2. A two-part carbonless NJPB form;

i. The top copy shall comply with the requirements of N.J.A.C. 13:45A-
27.8;

ii. The second copy shall be yellow and may contain the prescriber
information required pursuant to N.J.A.C. 13:45A-27.8;

3. Micro-perforated four inches by five and one half inches computer
ready NJPBs imprinted with all the prescriber information required pursuant
to N.J.A.C. 13:45A-27.8, which are capable of being computer printed
from a laser printer <<-cassette tray->>; and

4. Micro-perforated four inches by five and one half inches continuous
pin- fed NJPBs imprinted with all the prescriber information required
pursuant to N.J.A.C. 13:45A-27.8, which are capable of being computer
printed through the use of dot-matrix or ink-jet printers.

(g) Vendors shall assign and maintain a unique NJPB batch number for
each order of NJPBs from a licensed prescriber or licensed healthcare
facility. Re- orders of NJPBs shall contain batch numbers sequentially
greater than the batch number assigned to any previous order. Batch
numbers shall consist of:

1. An alphabetic prefix assigned by the Division which represents
the identity of the vendor;

2. The date of printing in the following order: year, month, and day;
and

1. All NJPBs are to be produced under tight security, in secure plants
with access limited to authorized personnel. Any unfinished work related
to the production of the NJPBs shall be stored under secure, controlled
conditions.

2. NJPBs and materials used to produce NJPBs, including all disks,
plates, negatives, and inventory goods, shall be stored at the vendor
production site in a secure manner which protects against theft or loss;

3. Vendors shall not subcontract or assign any portion of the production
of NJPBs without the prior approval of the Division;

4. If an applicant intends to subcontract any portion of NJPBs, the
applicant shall provide the subcontractor company name, address, telephone
number, ownership, and equipment list as part of the vendor's NJPB program
application to the Division;

5. The subcontractor shall provide to the Division details regarding
its production of any portion of the NJPBs and the security which will
be provided. The vendor and the subcontractor shall sign and submit
a completed form supplied by the Division which states that the parties
understand and agree to the contract specifications and the regulations
of this subchapter.

6. Vendors shall not add, transfer or discontinue the services of
a subcontractor without prior approval by the Division. Vendors shall
notify the Division of such changes in writing by mail, return receipt
requested. Within 14 days of the discontinuance of the services of a
subcontractor, an approved vendor shall retrieve all NJPB materials
from the subcontractor and shall submit a certification to the Division
verifying the retrieval;

7. Vendors shall assure that damaged NJPBs are destroyed and shall
maintain records indicating the date and method of destruction; and

8. Vendors shall report to the Division any theft, loss, damage, alteration,
or unauthorized use of NJPBs as soon as possible but no later than 72
hours of discovery.

(a) Vendors shall maintain the confidentiality of all data, documents,
files and computer records received from, or access through, the Division,
relating to the production, storage and distribution of NJPBs.

(b) Vendors shall certify, prior to being granted approved vendor
status, that they will protect the confidentiality of all data related
to prescribers and healthcare facilities for whom they print NJPBs,
and all data collected in order to accomplish any NJPB related function.

(c) Vendors shall return all documents, files and records supplied
by the Division, and all copies thereof, upon the vendor's termination
or voluntary withdrawal from the NJPB program.

<< NJ ADC 13:45A-27.12 >>

13:45A-27.12 Enforcement

(a) Vendors shall permit the Division or its authorized representative
to inspect any facility utilized in the production, storage, or distribution
of NJPBs. Inspections may be conducted for a period of five years following
the withdrawal or termination of a vendor from the NJPB program.

(b) Vendors shall provide the Division or its authorized representative
access to all records relating to the printing and distribution of NJPBs,
including financial records. Such records shall be maintained for five
years following a vendor's termination or voluntary withdrawal from
the NJPB program.

(c) Failure to comply with any of the requirements of this subchapter
or the contract specifications may result in suspension, the placement
of conditions on, or the permanent termination of the vendor from the
NJPB program consistent with the requirements of N.J.A.C. 13:45A-27.7.

<< NJ ADC 13:45A-27.13 >>

13:45A-27.13 Renewal of approved vendor status

Vendors shall submit an application for renewal of approved vendor
status, on a form supplied by the Division, <<-within 90 days
following the effective date of this section->> <<+by September
19, 2004+>> and, thereafter, vendors shall apply for renewal of
approved vendor status on a triennial basis.